Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1. doi: 10.1038/nrd.2016.189.

Authors

Sean Khozin¹, Meredith Chuk¹, Tamy Kim¹, Geoffrey Kim¹, Richard Pazdur¹, Suranjan De², Sanjay Sahoo²

Affiliations

¹ Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
² Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland 20993, USA.

PMID: 27681787
DOI: 10.1038/nrd.2016.189

No abstract available

Publication types

News

MeSH terms

Computers / standards*
Computers / trends
Device Approval / standards*
Drug Approval*
Humans
Research Report / standards*
Research Report / trends
Safety
United States
United States Food and Drug Administration / standards*
United States Food and Drug Administration / trends